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Study on Calcium Folinate to Reduce Pemetrexed Side Effects in Patients with Non-Small Cell Lung Cancer, Mesothelioma, or Thymoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for certain types of cancer, specifically Non-Small Cell Lung Cancer (NSCLC), Mesothelioma, and Thymoma. The treatment being tested is called Rescuvolin, which contains the active substance calcium folinate. This medication is being used to see if it can help reduce side effects caused by another cancer treatment called pemetrexed.

The purpose of the study is to evaluate how well calcium folinate can prevent or lessen the side effects, particularly those affecting blood cells, when used alongside pemetrexed. Participants in the study will be randomly assigned to receive either the calcium folinate treatment or a placebo, in addition to their regular cancer treatment. The study will monitor the participants over a period of time to observe any changes in their health, especially focusing on blood cell counts and other potential side effects.

Throughout the study, participants will take the medication in the form of tablets, and their health will be closely monitored by healthcare professionals. The study aims to provide valuable information on whether calcium folinate can effectively reduce the side effects of pemetrexed, potentially improving the quality of life for patients undergoing treatment for these types of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to confirm your eligibility. This includes being at least 18 years old, being eligible for treatment with pemetrexed-based chemotherapy, having an ECOG performance score of 0-2, and being able and willing to sign the informed consent form.
Step 2
Initial assessment
An initial assessment will be conducted to establish baseline health metrics. This includes measuring your neutrophil count and homocysteine plasma levels.
Step 3
Treatment phase
You will begin treatment with pemetrexed-based chemotherapy. During this phase, you will also receive Rescuvolin 15 mg tablets containing calcium folinate, taken orally. The dosage and frequency will be determined by the study protocol.
Step 4
Monitoring and follow-up
Your health will be monitored regularly to assess the effects of the treatment. This includes checking your neutrophil count on days 8-10 to evaluate any changes.
Additional assessments will be conducted after the second and fourth cycles of treatment to evaluate the efficacy of the therapy. This will involve a response CT scan to determine the response, partial response, or progression of the condition.
Step 5
Completion of the study
Upon completion of the study, a final assessment will be conducted to evaluate the overall impact of the treatment. This will include reviewing any incidence of discontinuation, dose delays, or dose reductions.

Who can join the trial?

5 criteria

You must be at least 18 years old.
You must have a type of lung cancer called non-small cell lung cancer (NSCLC), or have mesothelioma or thymoma.
You must be eligible for treatment with a specific type of chemotherapy called pemetrexed-based chemotherapy.
You must have an ECOG performance score between 0 and 2. This score is a way to measure how well you can perform daily activities. A score of 0 means you are fully active, and a score of 2 means you are up and about more than half of the day but cannot work.
You must be able and willing to sign an Informed Consent Form, which means you understand the study and agree to participate.

Who cannot join the trial?

5 criteria

Patients with any other type of cancer besides non-small cell lung cancer (NSCLC), mesothelioma, or thymoma cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.
Patients who are currently participating in another clinical trial cannot participate in this study.

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Verified sites

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Albert Schweitzer Ziekenhuis
Dordrecht, The Netherlands
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Amphia Hospital
Breda, The Netherlands

Trial locations

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Investigated drugs

Pemetrexed
is a medication used in cancer treatment. It works by interfering with the growth of cancer cells, slowing down or stopping their spread in the body. In this trial, pemetrexed is being studied to see how it affects blood cells, particularly focusing on a condition called neutropenia, which is a low count of a type of white blood cell that helps fight infections.
Folinic Acid
is a form of vitamin B that is used to reduce the side effects of certain cancer medications. In this trial, folinic acid is being used as a "rescue therapy" to help protect healthy cells from the harmful effects of pemetrexed. The goal is to see if folinic acid can help reduce the risk of neutropenia and other side effects caused by pemetrexed.

Calcium Folinate

What is already known about the treatment

Pemetrexed – Pemetrexed is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently used in medicine to treat certain types of cancer, specifically non-small cell lung cancer, mesothelioma, and thymoma. The drug works by interfering with the cancer cells' ability to make and repair DNA, which is essential for their growth and multiplication. Pemetrexed is classified as an antimetabolite, a type of chemotherapy drug that targets rapidly dividing cells.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and can spread to other parts of the body. The disease progresses through stages, starting from a localized tumor to more advanced stages where it spreads to lymph nodes and other organs. Symptoms may include a persistent cough, chest pain, and difficulty breathing. As the disease advances, it can lead to more severe respiratory issues and systemic symptoms. The progression rate can vary depending on the subtype and individual patient factors.
Mesothelioma
Mesothelioma is a rare cancer that affects the mesothelium, a thin layer of tissue covering most internal organs. It is most commonly found in the lining of the lungs and chest wall, known as pleural mesothelioma. The disease progresses as cancer cells grow and spread, often leading to symptoms such as chest pain, shortness of breath, and fluid buildup around the lungs. Over time, it can invade nearby tissues and organs, causing more severe symptoms. The progression can be slow or rapid, depending on various factors, including the type of mesothelioma and the patient's overall health. It is primarily associated with asbestos exposure.
Thymoma
Thymoma is a tumor originating from the epithelial cells of the thymus, a small organ located in the upper chest. It is generally slow-growing and can be asymptomatic in its early stages. As it progresses, thymoma may cause symptoms such as cough, chest pain, and difficulty swallowing due to its location near the lungs and heart. The tumor can invade surrounding tissues and, in some cases, spread to other parts of the body. Thymoma is often associated with autoimmune conditions, such as myasthenia gravis. The progression and behavior of thymoma can vary widely among individuals.